NCT Number: NCT03794726
This study will compare orthodontic molar protraction with and without adjunctive periodontally accelerated osteogenic orthodontic (PAOO) surgery prior to orthodontic tooth movement.
To the investigators' knowledge, this type of molar retraction in adult patients has not been compared with and without the adjunctive use of PAOO for differences in clinical linear tooth movement and patient centered outcomes (discomfort, change in daily activities, satisfaction with esthetic outcomes) in a controlled study.
Trial opening soon.
Get Notified18 year–99 year
All sexes
Interventional
Not applicable
Research data and daily clinical observations reveal that molar protraction (forward movement) in adult patients may be prolonged and ideal outcomes may not be achieved with traditional orthodontic tooth movement. One method for enhancing orthodontic tooth movement is the use of surgical access of the local site to initiate a regional tissue reaction to induce trauma, which leads to a limited inflammatory healing process. This process is also known as regional acceleratory phenomenon (RAP), which allows for more rapid bone turnover and has been shown in other protocols to enhance orthodontic tooth movement. While PAOO has been shown to rapidly increase tooth movement, to our knowledge, localized use of PAOO in combination with molar protraction in adults has not been evaluated in a prospective trial for differences in clinical outcomes (tooth movement time, adverse orthodontic outcomes, periodontal and soft tissue defects) and patient-centered outcomes (pain, swelling, change in daily activities, patient assessment of surgical benefit, and patient-assessed esthetics) in a controlled study.
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Molar Protraction with Orthodontic Tooth Movement and Adjunctive Periodontally Accelerated Osteogenic Orthodontics (PAOO) Surgery was performed on all study sites in this arm in coordination with standard orthodontic molar protraction using traditional bands/brackets and orthodontic wires.
Standard orthodontic molar protraction using traditional bands/brackets and orthodontic wires.
Time frame: From baseline to 3months
Compare the clinical linear molar tooth movement over a 3 month time frame (Baseline to 3 months) between two groups receiving orthodontic therapy alone or in combination with periodontally accelerated osteogenic orthodontics (PAOO).
Time frame: From baseline to 3months
Compare the radiographic mesial inclination of the molar to be protracted over a 3-month time frame (Baseline to 3 months) between two groups receiving orthodontics therapy alone or in combination with periodontally accelerated osteogenic orthodontics (PAOO).
Time frame: From baseline to 3months
Compare the periodontal probing depth (PD) at six sites per tooth at treated teeth over a 3-month time frame (Baseline to 3 months) between two groups receiving orthodontics therapy alone or in combination with periodontally accelerated osteogenic orthodontics (PAOO).
Time frame: From baseline to 3months
Compare the clinical attachment level (CAL) at six sites per tooth at treated teeth over a 3-month time frame (Baseline to 3 months) between two groups receiving orthodontics therapy alone or in combination with periodontally accelerated osteogenic orthodontics (PAOO).
Time frame: From baseline to 3months
Compare the width of keratinized tissue (KT) at up to two sites per tooth at treated teeth over a 3-month time frame (Baseline to 3 months) between two groups receiving orthodontics therapy alone or in combination with periodontally accelerated osteogenic orthodontics (PAOO).
Time frame: From baseline to 3months
Compare the width of attached tissue at up to two sites per tooth at treated teeth over a 3-month time frame (Baseline to 3 months) between two groups receiving orthodontics therapy alone or in combination with periodontally accelerated osteogenic orthodontics (PAOO).
Time frame: From baseline to 3months
Compare the practitioner-assessed esthetic outcomes using the pink esthetic score (PES) (Belser et al., 2009) over a 3-month time frame (Baseline to 3 months) between two groups receiving orthodontics therapy alone or in combination with periodontally accelerated osteogenic orthodontics (PAOO). This score is a grid which assesses mesial and distal papilla fill on a 0-2 scale, curvature of facial gingiva on a 0-2 scale, level of facial gingiva on a 0-2 scale, and root convexity/soft tissue color and contour on a 0-2 scale for an overall maximum assessment of 10 for esthetics. A 10 score would be considered ideal esthetics and a 0 would be considered least desirable. Each individual component of the PES is summed to provide the ultimate PES score.
Time frame: From baseline to 3months
Compare the patient-assessed satisfaction with esthetic outcomes over a 3-month time frame (Baseline to 3 months) between two groups receiving orthodontics therapy alone or in combination with periodontally accelerated osteogenic orthodontics (PAOO) using a visual analog scale from 0-100mm to determine the patients' assessment of their esthetic outcome.
Time frame: From baseline to 3months
Compare treatment discomfort over a 3-month time frame (Baseline to 3 months) between two groups receiving orthodontics therapy alone or in combination with periodontally accelerated osteogenic orthodontics (PAOO) using a visual analog scale from 0-100mm to determine the patients' assessment of the post-operative discomfort.
Time frame: From baseline to 3months
Compare treatment overall treatment satisfaction over a 3-month time frame (Baseline to 3 months) between two groups receiving orthodontics therapy alone or in combination with periodontally accelerated osteogenic orthodontics (PAOO) using a visual analog scale from 0-100mm to determine the patients' assessment of the patient's global assessment of treatment outcomes.
Time frame: From baseline to 3months
Compare assessment of post-treatment change in daily activities over a 3-month time frame (Baseline to 3 months) between two groups receiving orthodontics therapy alone or in combination with periodontally accelerated osteogenic orthodontics (PAOO) using a visual analog scale from 0-100mm to determine the patients' assessment of the post-operative changes to daily activities.
Contact information is provided by the study sponsor or research team.
University of Alabama at Birmingham
Other
A Prospective, Randomized Clinical Trial to Compare Orthodontic Molar Protraction With and Without Adjunctive Periodontally Accelerated Osteogenic Orthodontic (PAOO) Surgery.
Acronym: PAOO
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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